Sponsor users, typically clinical data managers and medical monitors, manually review the visits, forms, and items; issue queries; and record that the visits, forms, and items have been reviewed. This approach applies to the various types of reviews supported; for example, remote review and source verification. Only patients, visits, forms, and items that have no open queries or that were left blank intentionally can be marked as reviewed.
If there is a change to the data, the reviewer can change the status to Unmarked, negating the completed review of the patient, visit, form, or item.
Because of the hierarchical nature of the OutcomeLogix application:
The hierarchy works top-down as well. If you mark a patient as reviewed, the patient visits, forms, and items are marked as reviewed.
The Patient List page appears.
The Patient Summary page appears.
The form status changes. In the case of repeating forms, the form refreshes and remains open.
Icons for different types of reviews
Icons | Review Type |
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| SDV: Source Document Verification. |
| DM: Reviewed by a data manager. |
| Remote: Reviewed away from the site. |
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